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U.S. Department of Health and Human Services

Class 2 Device Recall Powerheart G5 Automatic AED

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 Class 2 Device Recall Powerheart G5 Automatic AEDsee related information
Date Initiated by FirmJune 04, 2019
Create DateJuly 03, 2019
Recall Status1 Terminated 3 on November 15, 2021
Recall NumberZ-1938-2019
Recall Event ID 83103
PMA NumberP160033 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductPowerheart G5 Automatic AED
Code Information Model Number G5A 80A;   AED Serial Number (UDI Number): D00000133922 )(01)00812394021222(11)190508(21)D00000133922), D00000133927 ((01)00812394021222(11)190509(21)D00000133927), D00000133930 ((01)00812394021222(11)190509(21)D00000133930), D00000133934 ((01)00812394021222(11)190509(21)D00000133934), D00000133936 )(01)00812394021222(11)190509(21)D00000133936).
FEI Number 2112020
Recalling Firm/
Manufacturer		 Cardiac Science Corporation
500 Burdick Pkwy
Deerfield WI 53531-9692
For Additional Information Contact
800-426-0337
Manufacturer Reason
for Recall		Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
FDA Determined
Cause 2		Process control
ActionCardiac Science Corporation notified customers of the recall on about 06/04/2019 via phone call and "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Customers were instructed to examine inventory, remove any affected devices, and contact Cardiac Science immediately to arrange for return of affected devices and replacement of new devices. Contact can be made by phone to 800.426.0337 option 1 or by email at techsupport@cardiacscience.com. Distributors were instructed to determine who received the affected devices, inform customers that a Cardiac Science representative will contact them and provided a list with customer names, contact information (including phone and email addresses) and affected device serial numbers to Cardiac Science. The list can be provided by calling 800.426.0337 or by emailing it to techsupport@cardiacscience.com.
Quantity in Commerce5 devices
DistributionUS distribution to Georgia, Texas, and Wisconsin.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
PMA DatabasePMAs with Product Code = MKJ
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